Catheter having movable tubular structure and proximal stopper

ABSTRACT

Catheter including an inner tubular member, an outer tubular member movable relative to the inner tubular member, and a movable tubular structure coupled to the outer tubular member. A medical device disposed about a distal end portion of the inner tubular member. A proximal stopper is provided having a distal end and disposed proximal to a proximal end of the movable tubular structure. The distal end of the proximal stopper is spaced from the proximal end of the movable tubular structure at least a longitudinal length dimension of the medical device, wherein the outer tubular member and the movable tubular structure are movable in a proximal direction up to engagement of the proximal stopper to deploy the medical device from the inner tubular member.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a U.S. National Stage Patent Application under 35U.S.C. § 371 of International Application No. PCT/US2013/068306, filedon Nov. 4, 2013, which is a continuation-in-part of and claims priorityto each of the following applications: U.S. application Ser. No.13/467,660, entitled “Catheter having Hydraulic Actuator” filed on May9, 2012; U.S. application Ser. No. 13/467,679, entitled “Catheter havingDual Balloon Hydraulic Actuator” filed on May 9, 2012; U.S. applicationSer. No. 13/467,715, entitled “Catheter having Hydraulic Actuator withTandem Chambers” filed on May 9, 2012; U.S. application Ser. No.13/801,588, entitled “Catheter Having Movable Tubular Structure” filedon Mar. 13, 2013; U.S. application Ser. No. 13/797,636, entitled,“Catheter Having Hydraulic Actuator And Locking System” filed on Mar.12, 2013; the disclosure of each of which is incorporated herein byreference in its entirety.

BACKGROUND OF THE DISCLOSED SUBJECT MATTER

Field of the Disclosed Subject Matter

The disclosed subject matter relates to catheters used in the deliveryof medical devices such as self-expanding stents for treating theluminal systems of a patient. Specifically, the disclosed subject matterrelates to a delivery catheter having a retractable sheath moved by ahydraulic actuator and stopped by a proximal stopper.

Description of the Related Art

A variety of systems using a retractable sheath are known forintraluminal delivery of a medical device, such as a stent or filter.However, there remains a need for continued improvement of such knowndelivery systems.

An example of such a system is described in U.S. Pat. No. 6,425,898 toWilson et al., which is incorporated by reference herein, wherein adelivery system is provided having an inner member with a stop attachedto the inner member. During deployment, the stop prevents the stent frommigrating proximally during retraction of the sheath for stentdeployment.

Conventional medical device delivery systems generally comprise a handleportion and an elongated shaft, wherein a medical device such as a stentis disposed within a delivery portion at the distal end of the shaft. Todeploy the stent, an outer sheath is provided which can be retractedrelative to the stent to release the stent from its deliveryconfiguration. The sheath in such systems generally spans the fulllength of the catheter resulting in an increased profile and stiffnessover the entire length of the catheter. Such stiffness and increasedprofile at the distal end of the catheter can restrict certainapplications, such as neuro and other indications of particular sizelimitations. Further, because the sheath spans the full length of thecatheter there is an increased risk of the sheath binding with othercomponents of the catheter during passage through the tortuous luminalsystem of a patient, thus inhibiting the deployment of the stent.

Another issue with such delivery systems is that the sheath is generallypulled back in a 1-to-1 ratio with the user's input (force). Because thestent may embed in the outer sheath during storage and shipping, and dueto larger static friction forces, a large amount of initial input istypically required to release the stent which may lead to incorrectplacement. When initially releasing the stent, it may be desirable toslowly pull back the sheath for proper placement and then more readilyretract the sheath to prevent inadvertent movement of the stent.

Further, the amount of force that is required to retract the sheath,particularly for stents of greater length as required for peripheralindications, can be substantial. To overcome this issue, a lubriciousliner can be used to decrease the amount of force required to retractthe sheath. However, there remains a need for an improved deliverysystem for self-expanding stents having reduced force requirements fordelivery of a self-expanding stent or the like.

Another issue with such delivery systems is that the mechanisms todeliver the medical device can be disposed within the luminal system ofa patient, which can increase the profile of the catheter to deliver themedical device. Such large profile catheters are unable to travel tocertain lesion sites to allow the medical device to reach the lesion.

There thus remains a continued need for an efficient and economic systemfor delivering a medical device that is easy to use and providesaccurate placement. The presently disclosed subject matter satisfiesthese and other needs.

SUMMARY OF THE DISCLOSED SUBJECT MATTER

The purpose and advantages of the disclosed subject matter will be setforth in and are apparent from the description that follows, as well aswill be learned by practice of the disclosed subject matter. Additionaladvantages of the disclosed subject matter will be realized and attainedby the devices particularly pointed out in the written description andclaims hereof, as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the disclosed subject matter, as embodied and broadly described, thedisclosed subject matter includes a catheter comprising, among otherthings, an inner tubular member having a proximal end portion, a distalend portion and an exterior surface, the inner tubular member furtherhaving a guidewire lumen defined therein. An outer tubular member ismovable relative to the inner tubular member, the outer tubular memberhaving a proximal end, a distal end and an interior surface directedtoward the exterior surface of the inner tubular member. A medicaldevice is disposed about the distal end portion of the inner tubularmember, the medical device having a longitudinal length dimension. Amovable tubular structure is coupled to the outer tubular member and aproximal stopper having a distal end is disposed proximal to a proximalend of the movable tubular structure. The distal end of the proximalstopper is spaced from the proximal end of the movable tubular structureat least the longitudinal length dimension of the medical device,wherein the outer tubular member and the movable tubular structure aremovable in a proximal direction up to engagement of the proximal stopperto deploy the medical device from the inner tubular member.

In accordance with another aspect of the disclosed subject matter, thedisclosed subject matter includes a catheter comprising, among otherthings, an inner tubular member having a proximal end portion, a distalend portion and an exterior surface, the inner tubular member furtherhaving a guidewire lumen and a fluid lumen defined therein, the fluidlumen having a fluid flow port defined by the exterior surface along thedistal end portion of the inner tubular member. An outer tubular memberis movable relative to the inner tubular member, the outer tubularmember having a proximal end, a distal end and an interior surfacedirected toward the exterior surface of the inner tubular member. Afirst movable tubular structure is coupled to the outer tubular memberand is disposed at the proximal end of the outer tubular member. Asecond movable tubular structure is coupled to the outer tubular memberand disposed at the distal end of the outer tubular member. A distalsheath is coupled to the outer tubular member by the second movabletubular member, the distal sheath movable relative the inner tubularmember by movement of the outer tubular member. A proximal seal extendsfrom the interior surface of the outer tubular member toward theexterior surface of the inner tubular member, the proximal seal beinglocated proximal to the fluid flow port. A distal seal extends from theexterior surface of the inner tubular member toward the interior surfaceof the outer tubular member, the distal seal located distal to the fluidflow port. A pressure chamber is defined by the proximal seal, thedistal seal, the exterior surface of the inner tubular member, andinterior surface of the outer tubular member. The pressure chamber isdisposed proximal to the first movable tubular structure and in fluidcommunication with the fluid flow port, wherein fluid introduced throughthe fluid flow port and into the pressure chamber applies a force on theproximal seal to urge the outer tubular member, the first movabletubular structure, and the second movable tubular structure in theproximal direction.

In accordance with another aspect of the disclosed subject matter, amethod of making a catheter comprising, among other things, providing aninner tubular member having a proximal end portion, a distal end portionand an exterior surface, the inner tubular member further having aguidewire lumen defined therein; providing a medical device disposedabout the distal end portion of the inner tubular member, the medicaldevice having a longitudinal length dimension; providing an outertubular member movable relative to the inner tubular member, the outertubular member having a proximal end, a distal end and an interiorsurface directed toward the exterior surface of the inner tubularmember; coupling a movable tubular structure to the outer tubularmember; and providing a proximal stopper having a distal end anddisposed proximal to a proximal end of the movable tubular structure,the distal end of the proximal stopper being spaced from the proximalend of the movable tubular structure at least the longitudinal lengthdimension of the medical device, wherein the outer tubular member andthe movable tubular structure are movable in a proximal direction up toengagement of the proximal stopper to deploy the medical device from theinner tubular member.

It is to be understood that both the foregoing general description andthe following detailed description and drawings are examples and areprovided for purpose of illustration and not intended to limit the scopeof the disclosed subject matter in any manner.

The accompanying drawings, which are incorporated in and constitute partof this specification, are included to illustrate and provide a furtherunderstanding of the devices of the disclosed subject matter. Togetherwith the description, the drawings serve to explain the principles ofthe disclosed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter of the application will be more readily understoodfrom the following detailed description when read in conjunction withthe accompanying drawings, in which:

FIG. 1 is a schematic side view of a representative catheter inaccordance with the disclosed subject matter.

FIG. 2 is a perspective view of the distal end section of the catheterof FIG. 1.

FIG. 3A is a cross sectional perspective view of the catheter of FIG. 2taken along line 3-3.

FIG. 3B is a cross sectional perspective view of another embodiment ofthe catheter of FIG. 2 taken along line 3-3.

FIG. 4 is a cross sectional perspective side view of the distal endsection of a catheter in accordance with the disclosed subject matterwith the sheath in a closed position.

FIG. 5A is a detailed view of a movable tubular structure in accordancewith a representative embodiment of the disclosed subject matter.

FIG. 5B is a detailed view of a catheter with the movable tubularstructure of FIG. 5A in accordance with the disclosed subject matter.

FIG. 5C is a detailed view of another representative embodiment of themovable tubular structure in accordance the disclosed subject matter.

FIG. 6 is a cross sectional side view of the distal end of the catheterof FIG. 4 with the sheath in a fully retracted position.

FIG. 7 is a cross sectional side view of the distal end section of analternative catheter in accordance with the disclosed subject matterwith the sheath in a fully retracted position.

FIG. 7A is a cross sectional view of the catheter of FIG. 7 taken atline 7A.

FIG. 8 is a cross sectional view of a catheter having a pressure chamberwith proximal and distal movable tubular structures, in accordance withanother representative embodiment of the disclosed subject matter.

FIG. 9 is a cross sectional view of a catheter having a distal movabletubular structure couple the outer tubular member with a distal sheath,in accordance with yet another representative embodiment of thedisclosed subject matter.

FIG. 10 is a detail perspective view of the catheter of FIG. 4 alongline FIG. 10.

FIG. 11 is a cross sectional perspective view of the detail of FIG. 10.

FIG. 12 is a schematic side view of a representative catheter inaccordance with an embodiment of the disclosed subject matter.

FIG. 13 is a schematic side view of a representative catheter inaccordance with an embodiment of the disclosed subject matter.

FIG. 13A is a cross sectional view of the catheter of FIG. 13 taken atline 13A.

DETAILED DESCRIPTION

Reference will now be made in detail to embodiments of the disclosedsubject matter, an example of which is illustrated in the accompanyingdrawings. The disclosed subject matter will be described in conjunctionwith the detailed description of the system.

As disclosed herein, the devices presented herein can be used fortreating the luminal system of a patient. In particular, the disclosedsubject matter is particularly suited for treatment of cardiovascularand the peripheral systems of a patient.

In accordance with the disclosed subject matter, a catheter is providedcomprising, among other things, an inner tubular member having aproximal end portion, a distal end portion and an exterior surface, theinner tubular member further having a guidewire lumen defined therein.An outer tubular member is movable relative to the inner tubular member,the outer tubular member having a proximal end, a distal end and aninterior surface directed toward the exterior surface of the innertubular member. A medical device is disposed about the distal endportion of the inner tubular member, the medical device having alongitudinal length dimension. A movable tubular structure is coupled tothe outer tubular member and a proximal stopper having a distal end isdisposed proximal to a proximal end of the movable tubular structure.The distal end of the proximal stopper is spaced from the proximal endof the movable tubular structure at least the longitudinal lengthdimension of the medical device, wherein the outer tubular member andthe movable tubular structure are movable in a proximal direction up toengagement of the proximal stopper to deploy the medical device from theinner tubular member.

Solely for purpose of illustration, an exemplary embodiment of ahydraulic delivery system for a self-expanding stent or the like, isshown schematically in FIGS. 1 and 2. The examples herein are notintended to limit the scope of the disclosed subject matter in anymanner. Particularly, and as illustrated, the hydraulic delivery systemembodied herein is a catheter 100 for cardiovascular intervention or thelike, Catheters for other interventions, such as peripheral and belowthe knee interventions, are contemplated herein. The catheter 100includes an inner tubular member 110 having a proximal end portion, adistal end portion, and an exterior surface. The catheter 100 furtherincludes an outer tubular member or sheath 120 which is movable relativeto the inner tubular member 110 and has a proximal end, a distal end andan interior surface directed toward the exterior surface of the innertubular member 110. As shown in FIG. 2, the outer tubular member 120 isdisposed only at a distal end portion of the catheter in thisembodiment. For other embodiments, the outer tubular member 120 can bedisposed at the proximal end portion and/or the distal end portion ofthe catheter. As described further herein, the catheter of the disclosedsubject matter can be configured to deliver a medical device, such as astent, of any suitable length. That is, the catheter can be configuredto generate a force sufficient to retract the outer tubular member,wherein the generated force is greater than the resistance force causedby the medical device acting on the outer tubular member.

Solely for purpose of illustration, reference is made to FIG. 3A whichdepicts a representative cross sectional view of an exemplary innertubular member 110 along lines 3-3 of FIG. 2, in accordance with thedisclosed subject matter. The inner tubular member 110 further has afluid lumen 310 defined therein. In one embodiment the inner tubularmember can also have a guidewire lumen 320 defined at least along alength therein. For example, the guidewire lumen 320, if provided, canextend over the entire length of the inner tubular member 110 such asfor an “over-the-wire” configuration, or only along a distal length suchas for a “rapid exchange” embodiment. Alternatively the catheter 100 canhave a single-lumen design and the guidewire and pressurized fluid canshare the same lumen (not shown), wherein a seal or valve can beprovided at distal and proximal ends.

FIG. 3B depicts another embodiment of a representative cross sectionalview of an exemplary inner tubular member 110 along lines 3-3 of FIG. 2.In this embodiment, as shown in FIG. 3B solely for purposes ofillustration, the guidewire lumen 320 can be defined at least in part bya separate guidewire tube 321 disposed within a fluid lumen 310 andsealed at either side, such as for example, by a marker (not shown).Such coaxial configurations allow for reduced diameter of the innertubular member 110, and thus reduced profile. Indeed the guidewire tube321 defining the guidewire lumen 320 can be formed by a thin membrane ofsuitable strength to prevent the guidewire from penetratingtherethrough. Hydraulic fluid can thus flow within the fluid lumen 310but outside the guidewire lumen 320.

Solely for purpose of illustration, reference is now made to a rapidexchange configuration of the catheter disclosed herein as shown in FIG.4. Generally, the catheter includes an inner tubular member 110 having aproximal end portion, a distal end portion and an exterior surface. Theinner tubular member 110 further includes a fluid lumen 310 having afluid flow port 420 defined by the exterior surface 111 along a distalend portion of inner tubular member 110. The outer tubular member 120 ismovable relative to the inner tubular member 110 and has a proximal end,a distal end and an interior surface 121 directed toward the exteriorsurface 111 of the inner tubular member 110. As described in more detailbelow, the fluid flow port 420 allows fluid to pass from within fluidlumen 310 into the space defined by the inner tubular member 110 andouter tubular member 120 for operation and retraction of the outertubular member 120. A marker 422 can define the distal end of the fluidflow port 420. As embodied herein, the rapid exchange catheter furtherincludes guidewire lumen 320 extending along a distal end portion of thecatheter and including a proximal guidewire port 410 and a distalguidewire port 430.

As illustrated, the outer tubular member 120 can be moved from anextended position as shown in FIG. 4 to a retracted position shown inFIG. 6. When extended, the outer tubular member 120 retains a medicaldevice, such as a stent 440 as depicted herein, in a compressed ordelivery condition. A distal tip 460 can also be provided at a distalend of the inner tubular member 110 to further enclose the medicaldevice during delivery. When the outer tubular member 120 is retracted(as shown in FIGS. 6 and 7), the medical device is unsheathed andallowed to expand to a deployed condition.

In accordance with the disclosed subject matter and as depicted in FIGS.4-7, the outer tubular member 120 further includes at least one movabletubular structure 130 is disposed between the outer tubular member 120and the inner tubular member 110. With reference to FIGS. 5A and 5B, adetailed view of the movable tubular structure 130 is provided,according to a representative embodiment of the subject matter. Themovable tubular structure 130 generally comprises a body member 131 withan outer surface having a recess 134 defined therein. As further shownin FIG. 5A, and as embodied herein, the body member 131 includes a tapersegment 132 and a base segment 133. However, embodiments of thedisclosed subject matter further include body member 131 without a tapersegment. FIG. 5A shows, for purposes of illustration, the recess 134 isdisposed in the base segment 133 of the body member 131. Alternativeembodiments of the disclosed subject matter likewise include one or morerecesses in the taper segment 132 and/or one or more recesses in thebase segment 133. For example, FIG. 5C depicts a movable tubularstructure 130 having a recess 134 being disposed in the taper segment132 of the body member 131 and additional recesses 134A and 134B beingdisposed in the base segment 133.

As disclosed herein, the recess 134 can be defined at least in part byat least one shoulder 137 proximate the outer surface to the body member131. The shoulder 137 has an angle relative the outer surface of thebody member 131. The angle of the shoulder relative the outer surfacecan range from approximately 70 degrees to approximately 110 degrees.For example, without limitation, as depicted in FIG. 5A, a shoulder 137can be formed at each end of the recess, with the angle of each shouldershown as substantially perpendicular. Furthermore, the recess has adepth d of any suitable dimensions. For example, with reference to FIG.5A and FIG. 5B, the depth d of the recess 134 can be approximately equalto or greater than a thickness t of the outer tubular member 120. Forexample, and with reference to a cardiovascular catheter, the thicknesst of the outer tubular member 120 is between approximately 0.0025 inchesto 0.0035 inches. The depth d can generally range from approximately0.002 inches to 0.006 inches. Other feasible dimensions for thethickness t and corresponding depth d can be permitted.

As depicted in FIG. 5B, and in accordance with the disclosed subjectmatter, the outer tubular member 120 is received within the recess 134to form a trough 135 along a portion of an exterior surface of the outertubular member 120. If more than one recess is provided, a secondportion of the outer tubular member can be received within the secondrecess to form a second trough.

As disclosed herein, and in accordance with the disclosed subjectmatter, the trough 135 has a filler 136 disposed therein to couple theouter tubular member 120 to the body member 131 of the movable tubularstructure 130. As embodied herein the filler 136 generally can have athickness h equal to the depth d of the recess 134. Accordingly, andwith reference to the exemplary dimensions above, the thickness h of thefiller can range from approximately 0.002 inches to approximately 0.006inches.

As embodied herein, an exterior surface of the filler 136 issubstantially flush with an exterior surface of the outer tubular member120 adjacent the recess 134. In this manner and as shown in FIG. 5B, atransition between the exterior surface of the filler 136 and theexterior surface of outer tubular member 120 adjacent the recess 134 issubstantially smooth. Furthermore, the filler is provided withadditional hoop strength to secure the portion of outer tubular memberwithin the recess of the moveable tubular structure. As depicted in FIG.5B, the filler 136 also abuts the shoulder 137 of the movable tubularstructure 130 with the outer tubular member sandwiched therebetween tocreate the grip and lock. The movable tubular structure 130 and theouter tubular member 120 are thus locked together by the filler 136.Since the outer tubular member 120 is movable with respect to the innertubular member 110, the movable tubular structure 130 moves with theouter tubular member 120.

The filler can be any suitable material capable of providing sufficienthoop strength to couple the outer tubular member with the recess of themovable tubular member. For example, the filler can comprise at leastone of nylon, fluoropolymer, peek, epoxy, platinum iridium, ceramic ormetal, such as a metal band or the like. In accordance with a particularaspect of the disclosed subject matter, the filler comprises a materialcompatible for thermal bonding with a material of the outer tubularmember. For example, the material of the filler can comprise the samematerial as the outer tubular member. The compatibility of the fillerand the outer tubular member thus allows for a more secure lock betweenthe outer tubular member and the moveable tubular structure, even if theouter tubular member is not thermally compatible with the movabletubular structure. Additionally, the increased thickness of outertubular member and filler bonded together with the recess provides astrength that a single layer material does not inherently comprise.Further, a substantially continuous surface of the adjacent outertubular member with the filler is provided by the heat bond to eliminatean area or edge that could potentially catch while the system is beingadvanced or withdrawn from the vasculature. Additionally, the mechanicallock created by the filler provides the strength to maintain theintegrity of the catheter components. The filler thus can bonded to theouter tubular member by at least one of heat bonding, thermal bonding,adhesive bonding, or the like, as well as by crimping or swaging of abond of suitable material.

The movable tubular structure can be disposed along the catheter at anysuitable location, depending upon the desired functions and need. Thecatheter can additionally include more than one movable tubularstructure. For example, and as embodied herein, as depicted in FIGS.4-7, the movable tubular structure 130 can be disposed at the proximalend of the outer tubular member 120. In this embodiment, the movabletubular structure includes a taper segment 132 extending from theproximal end of the outer tubular member 120. The catheter of FIGS. 4,6, and 7 only includes one movable tubular structure 130. Alternatively,or in addition thereto, the movable tubular structure can be disposed atthe distal end of the outer tubular member 120. In the embodiment ofFIG. 8, the catheter includes both a proximal movable tubular structure130 and a distal movable tubular structure 130′. The distal movabletubular structure 130′ has a taper segment 132 extending from the distalend of the outer tubular member. However, the proximal movable tubularstructure 130 and the distal movable tubular structure 130′ can furtherinclude other suitable configurations, such as, but not limited tocylinder-type structures with non-tapered segments.

The movable tubular structure can comprise or be made of any suitablebiocompatible material, such as PEEK. Because it is not necessary tobond the outer tubular member directly to the movable tubular structure,the movable tubular structure can comprise a material incompatible forthermal bonding with the material of the outer tubular member. As such,it is beneficial for the movable tubular structure to be made of asuitable material having a higher melt temperature than that of theouter tubular member and/or filler Thus, even upon application ofthermal energy or heat to the area of the movable tubular structure, themovable tubular structure can maintain its structural integrity. Themovable tubular structure can further include a PTFE liner or other lowfriction or lubricious layer, if desired.

In accordance with another aspect of the disclosed subject matter, adistal sheath can be provided, coupled to the outer tubular member bythe movable tubular structure. For purpose of illustration, and notlimitations, FIG. 9 depicts a catheter having a distal movable tubularstructure and distal sheath. As embodied here, the catheter comprises adistal sheath 140 coupled to the outer tubular member 120 by the distalmovable tubular member 130′. The distal sheath 140 is thus movable withthe outer tubular member 120 and the proximal movable tubular member130. Accordingly, the distal sheath 140 is movable relative the innertubular member 110 by movement of the outer tubular member 120.

As depicted, the distal sheath 140 can have an outer cross dimensionless than an outer cross dimension of the outer tubular member 120. Forexample, and for use in neuro indications the outer cross dimension ofthe outer tubular member 120 can be between approximately 2 French toapproximately 6 French whereas the distal sheath has an outer crossdimensions of from approximately 0.002 inches to approximately 0.003inches. The smaller dimension of the sheath 140 allows the sheath tohave a flexibility and a stiffness different than a flexibility andstiffness of the outer tubular member 120. As such, the stent, or anyother medical device can comprise an outer cross dimensional profileranging from approximately 2 French to approximately 6 French.

In alternative embodiments, the distal sheath 140 can have an outercross dimension greater than an outer cross dimension of the outertubular member 120. For example, the distal sheath can have an outercross dimensions of from approximately 2 French to approximately 6French and the outer tubular member has a smaller dimension. The smallerdimension of the outer tubular member 120 allows the catheter to have asmaller profile along the length of the catheter to be able to reachlesions positioned in more tortuous passages, as further discussedbelow. The larger profile at the distal sheath section enables a medicaldevice, such as a stent, to be disposed at the distal end of thecatheter. Furthermore, the distal sheath can have a flexibility and astiffness different than a flexibility and stiffness of the outertubular member, as desired.

In other embodiments, such as for neuro indications, the catheter at thedistal end along the sheath 140 has a greater flexibility and lessstiffness than the catheter along the outer tubular member 120. Inanother embodiment, such as for peripheral indications, such asbelow-the-knee procedures, the catheter can have less flexibility andgreater stiffness at a distal end e.g., to allow the distal tip to easethrough calcified lesions. The distal sheath thus can be made of thesame material as the outer tubular member, or can be made of a differentsuitable material depending upon the intended purpose. For example, thedistal sheath for neuro indications can comprise a more flexible softermaterial that a distal sheath for a below-the-knee indication.

A variety of configurations of the movable tubular structure can beprovided to couple the outer tubular member with the distal sheath. Forpurpose of illustration, and not limitation, and with reference to FIG.5C, the movable tubular structure can comprise a body member having abase segment with a first recess defined therein and a taper segmentwith a second recess defined therein. In this manner, the outer tubularmember can be coupled to the base segment of the movable tubularstructure by a filler as described above. Similarly, a portion of thedistal sheath can be disposed within the second recess of the taperedsegment of the movable tubular structure, and then a filler of suitablematerial can be disposed in the trough formed by the distal sheath inthe second recess to couple the distal sheath to the moveable tubularstructure in a similar manner. Although, the distal sheath can becoupled directly as shown in FIGS. 8-9.

As previously noted, and as embodied in FIGS. 4-7 and 9, the cathetercan be used for the delivery of medical devices, such as stents,disposed along the length of the catheter. The catheter embodied hereincan include a stent seat 510 for the initial placement of the stent 440.The stent seat 510 can be disposed proximate the distal end portion ofthe inner tubular member. However, depending on the intended use andindication, the stent 440 and stent seat 510 can be located at othersuitable locations along the catheter for the desired indication. Forexample, for cardiovascular indications, such as within the heart, thestent and the stent seat can be disposed at the distal end of thecatheter. As embodied in FIGS. 4-7, the stent seat 510 and the stent 440are disposed at the distal end of the catheter with the outer tubularmember 120 retaining the stent 440 at the stent seat. For neuroindications, such as procedures in the brain, the stent seat and thestent can be disposed distal to the outer tubular member at the distalend of the catheter. As embodied in FIG. 9, the distal movable tubularstructure 130′ couples a distal sheath 140 of smaller cross section withthe outer tubular member 120. In this embodiment, the distal sheath 140retains the stent 440 at the stent seat 410 and the catheter has asmaller cross dimension at the distal end for neuro application.Although reference is made to a stent and stent seat, for purpose ofillustration it is recognized that other medical devices also can bedelivered by and deployed from the catheter of the disclosed subjectmatter.

As previously discussed, the outer tubular member 120, and the movabletubular structure 130, as well as the distal the sheath 140, ifprovided, are movable with respect to the inner tubular member 110, suchas to release a medical device such as a stent 440 retained on thecatheter at the stent seat 510. To initiate movement of the componentsof the catheter, a suitable actuator is provided. The actuator can bedisposed at any suitable location along the catheter and external to abody lumen during use, that is capable of initiating movement of thecatheter components. For example, and in accordance with another aspect,the catheter can further include a hydraulic pressure chamber at asuitable location along the catheter. Examples of suitable hydraulicpressure chambers include U.S. application Ser. No. 13/467,660, entitled“Catheter Having Hydraulic Actuator” assigned to Abbott CardiovascularSystems Inc.; U.S. application Ser. No. 13/467,715, entitled “CatheterHydraulic Actuator with Tandem Chambers” assigned to AbbottCardiovascular Systems Inc.; and U.S. application Ser. No. 13/467,679,entitled “Catheter Having Dual Balloon Hydraulic Actuator” assigned toAbbott Cardiovascular Systems Inc., the contents of each of which isincorporated herein by reference in its entirety.

Solely for purpose of illustration, FIGS. 10 and 11 depict the pressurechamber 450, which is defined between proximal seal 720 and distal seal730. For purposes of discussion and illustration, other features of thecatheter and the pressure chamber are not illustrated herein, but can beunderstood from the more detailed descriptions incorporated by referenceherein. The proximal seal 720 extends from the interior surface of theouter tubular member 120 toward the exterior surface of the innertubular member 110 and is located proximal to fluid flow port 420. Theproximal seal 720 is fixed to the interior surface of the outer tubularmember 120 and moves freely relative to the inner tubular member 110.With reference to the embodiment of FIG. 4, the proximal seal 720 isdisposed distal to the movable tubular structure 130.

FIGS. 10 and 11 further depict distal seal 730 spaced from the proximalseal 720. The distal seal 730 extends from the exterior surface of theinner tubular member 110 toward the interior surface of the outertubular member 120 and is located distal to fluid flow port 420. Thedistal seal 730 is fixed to the exterior surface of the inner tubularmember 110 and moves freely relative to the interior surface of theouter tubular member 120. In this manner, the outer tubular member 120moves freely relative to the distal seal 730. As embodied herein, and asshown in FIG. 9, one or both of the proximal and distal seal can form awiper seal 740 across the corresponding surface. As such, and asdepicted in FIGS. 10 and 11, the pressure chamber is defined by theproximal seal 720, distal seal 730, the exterior surface 111 of theinner tubular member 110, and the interior surface 121 of the outertubular member 120. Pressure chamber 450 is in fluid communication withfluid flow port 420.

As recognized in the art, the outer tubular member 120 constrains themedical device to be delivered. The medical device, e.g., aself-expanding stent, is deployed by retracting the outer tubular member120 (catheter sheath). In other embodiments, as previously discussedwith respect to FIGS. 8-9, the outer tubular member 120 is connected tosheath 140 via a movable tubular structure 130. The distal sheath 140retains the stent and the stent is deployed by retracting the outertubular member 120 along with the distal sheath 140. Retraction isachieved by the introduction of fluid under pressure through the fluidlumen 310 using a conventional device, such as an indeflator or asyringe. The indeflator can include a threaded engagement or otherlocking mechanism to control pressurization and depressurization of thepressure chamber (not shown). Additionally, a pressure gauge can beprovided with the indeflator to monitor the pressure system of thecatheter. The indeflator can be configured to allow for the rapidrelease of hydraulic pressure to stop or inhibit the deployment of thestent. The indeflator can also be configured to create and/or maintainnegative pressure in the catheter. The indeflator can further create avacuum that decreases the profile of the catheter. For example, bycreating a vacuum, the outer tubular member 120 disclosed herein, can beconfigured to decrease in profile and/or lock in position. An example ofa suitable indeflator is an Atrion indeflator Atrion Medical—55 ATM.

An adapter can be provided at the proximal end of the catheter foraccess to the fluid lumen and can be configured for connecting to afluid source (not shown). With reference to FIG. 10, fluid is introducedinto the fluid lumen and exits the fluid lumen at flow port 420 andfills pressure chamber 450. Once sufficient fluid is introduced into thepressure chamber 450, a force is applied on the distal and proximalseals. Because the distal seal 730 is fixed relative to the innermember, only the proximal seal 720 and outer tubular member 120 attachedthereto is capable of movement relative to the inner member in theproximal direction P. Movement of the proximal seal 720 upon theapplication of force in the pressure chamber 450 urges the outer tubularmember 120, along with the movable tubular structure 130 and distalsheath 140 if provided, to move in the proximal direction P along theinner tubular member thereby allowing the medical device to be deployed.Distal seal 730, as embodied herein, is configured as a wiper-seal withthe interior surface of outer tubular member 120. The outer tubularmember 120, and the movable tubular structure 130 and sheath 140 ifprovided, thus move relative to distal seal 730. Proximal seal 720mounted to the interior surface of outer tubular member 120 isconfigured as a wiper-seal with the exterior surface 111 of innertubular member 110. The proximal seal 720 is free to move relative tothe inner tubular member 110.

Furthermore, by providing a movable tubular structure 130 and distalsheath 140, the pressure chamber 450 can be sufficiently spaced proximalto the distal end of the catheter and the stent seat for neuroindications or the like. For instance, the pressure chamber 450 can bespaced approximately 8 inches to approximately 20 inches from the stent410 and stent seat 510. This spaced relationship between the pressurechamber to the stent provides certain safety benefits if a mechanicalissue arises within the pressure chamber; e.g., maintains spacedrelations from the brain. However, in other embodiments as discussedfurther herein, the pressure chamber can be disposed at any locationalong the catheter. Indeed, the pressure chamber 450 can be disposed atthe proximal portion of the catheter.

As shown in FIGS. 12 and 13, the pressure chamber 450 can be disposed atthe proximal end of the catheter. In such embodiments, the pressurechamber, along with any associated movable tubular structure and/orseal, can be disposed external to a body lumen of a patient duringdeployment of the medical device. In further embodiments, the pressurechamber can be disposed between the proximal end of the catheter and thedistal end of the catheter. In the embodiment of FIG. 12, the movabletubular structure includes a proximal movable tubular structure 130 anda distal movable tubular structure 130′, as similarly described withrespect to FIG. 8. The proximal movable tubular structure 130 and thedistal movable tubular structure 130′ are disposed toward a proximal endof the catheter in this embodiment. Although the proximal movabletubular structure 130 is depicted as tapered and the distal movabletubular structure 130′ is depicted as cylindrical, the structures 130,130′ each can have any suitable shape and dimension as further discussedabove. The catheter can further include a subsequent movable tubularstructure 138 disposed at the distal end of the catheter, as furtherdiscussed herein.

Regardless of the positioning of the pressure chamber along thecatheter, the catheter can additionally include a proximal stopperdisposed proximal to the pressure chamber to limit the movement of themovable tubular structure in the proximal direction. FIG. 12 depicts aproximal stopper 801 disposed proximal to a proximal end of the proximalmovable tubular structure 130. Accordingly, the proximal stopper 801 canbe disposed proximate to and distal of the proximal adapter 101, asshown in FIG. 12. The proximal stopper can comprise any suitablematerial, such as, but not limited to the materials suitable for themovable tubular structures such as Polyetheretherketone (PEEK),Polyphenylene Sulfide (PPS), Polyether Imide (PEI), Polysulfone (PS).

As shown in this embodiment, the proximal stopper 801 includes a distalend 801B spaced from the proximal end 130A of the proximal movabletubular structure 130 at a distance L. The proximal stopper 801 can bespaced at any suitable distance L from the proximal end 130A of theproximal movable tubular structure 130. For example, the proximalstopper can be spaced from the movable tubular stopper at least thelongitudinal length dimension H of the medical device. The longitudinallength dimension H of the medical device can include any suitabledimension, such as a range from approximately 10 mm to approximately 250mm. The medical device prior to deployment can furthermore have anysuitable outer cross dimensional profile, such as ranging fromapproximately 2 French to approximately 6 French. In other embodiments,the distance L between the proximal stopper 801 and the movable tubularstructure 130 can be greater than the dimension H of the medical deviceto provide a sufficient tolerance for any shifting of the medical deviceduring delivery of the catheter. For example, the distance L can be anapproximate percentage of the dimension H in an embodiment. For purposesof example the distance L can be approximately 12 mm to approximately312 mm.

FIG. 12 depicts the medical device as a self-expanding stent 440,disposed at the distal end of the catheter with the outer tubular member120 surrounding the stent 440. The stent 440 has a longitudinal lengthdimension of L. In this embodiment, the longitudinal length dimension Lis approximately equal to the dimension H of the medical device.

In FIG. 12, the catheter additionally includes a second movable tubularstructure 138 at a distal end of the catheter and disposed proximal tothe medical device. The second movable tubular structure 138 can becoupled to the outer tubular member 120, as previously described withrespect to FIGS. 4 and 8. In this embodiment, a distal sheath 140 can beprovided to cover the medical device prior to deployment as furtherdiscussed herein. In such embodiments, the outer tubular member 120extends from the proximal movable tubular structure 130 to the secondmovable tubular structure 138. As such, the second movable tubularstructure 138 is coupled with the distal sheath 140, similar to theembodiment of FIG. 9. In such embodiments having a distal sheath inaddition to the outer tubular member, the distal sheath extends from thesecond movable tubular structure 138 to the distal tip 460 to cover thelongitudinal length of the medical device. Accordingly, the distalsheath can have a suitable hoop strength to cover and secure the medicaldevice. In yet further embodiments, an intermediate tubular member canextend between the distal end of the outer tubular member and theproximal end of the distal sheath. Such intermediate tubular member canhave the same or different material of construction, flexibility, and/orhoop strength as the outer tubular member or the distal sheath.

In other embodiments, the outer tubular member can extend distal to thesecond movable tubular structure 138. For example, the outer tubularmember can extend to the distal end of the catheter to cover the medicaldevice without the need of an additional distal sheath. In suchembodiments, the outer tubular member can be disposed over the secondmovable tubular structure 138 and coupled thereto by filler material, assimilarly discussed with respect to FIGS. 5A-5C.

With reference again to the embodiment of FIG. 12, upon activation ofthe pressure chamber 450 as described above, the outer tubular member120, coupled to the distal movable tubular structure 130′, moves in theproximal direction. As previously discussed with respect to FIG. 8, theproximal movable tubular structure 130 and the distal movable tubularstructure 130′ are movable together as a unit in the proximal direction.However, once the unit moves approximately the distance L in theproximal direction, the distal sheath 140 is entirely withdrawn fromsurrounding the self-expanding stent 440 and the self-expanding stent440 is deployed. The proximal stopper 801 prevents further proximalmovement of the proximal and distal movable tubular structures 130,130′. Once the unit is moved the distance L, the proximal end 130A ofthe proximal movable tubular structure 130 is engaged with the distalend 801B of the proximal stopper 801, thus preventing proximal furthermovement. As such, the proximal movable tubular structure 130, alongwith the outer tubular member 120, can be movable in the proximaldirection up to engagement of the proximal stopper 801 to deploy themedical device from the inner tubular member 110 and move the distalsheath in the proximal direction. In this embodiment, the outer tubularmember 120 and the distal sheath 140 are disposed along a majority ofthe length of the catheter up to the second movable tubular structure138. Other embodiments include the outer tubular member 120 disposedalong the length of the catheter distally beyond the second movabletubular structure 138 to cover the medical device.

FIG. 13 depicts another embodiment of the disclosed subject matter. Inthis embodiment, the catheter further includes at least one wire device820 to couple the second movable tubular structure 138 with one or bothof the movable tubular structures 130, 130′. The at least one wiredevice can be disposed within the catheter along a lumen definedtherein. For example, and as shown in FIG. 13, the at least one wiredevice can be disposed between the outer tubular member 120 and theinner tubular member 110.

FIG. 13A is a cross sectional view of the catheter of FIG. 13 taken atline 13A, which depicts the first and second wires of the wire devicedisposed between the inner tubular member 110 and the outer tubularmember 120. The at least one wire device further facilitates movement ofthe outer tubular member in the proximal direction with movement of thesecond movable tubular structure to deploy the medical device. In theembodiment of FIG. 13, the at least one wire device comprises a firstand second wire. However, the at least one wire device can include aplurality of suitable wires. For example, the at least one wire devicecan comprise up to approximately 10 wires. The wire device can compriseany suitable material, such as, but not limited to Nitinol or StainlessSteel.

According to a further embodiment, the movable outer tubular member canbe solely disposed at the distal end of the catheter to cover thelongitudinal length of the medical device. In such embodiment, the outertubular member extends in an initial position from the distal tip 460 ofthe catheter to the second movable tubular structure 138. As such, thesecond movable tubular structure 138 is coupled to the movable tubularstructure 130′ by the wire device alone. Accordingly, the wire device isdisposed about the inner tubular member and the outer tubular memberdoes not extend from the second movable tubular structure 138 to themovable tubular structure 130′.

According to a further embodiment, and as depicted in FIG. 13, theproximal end of the catheter inclusive of at least the adapter 101 andproximal stopper 801 can be embedded in a molded shell. The shell canprovide simplified use when using the catheter according to embodimentsof the disclosed subject matter.

Although shown as a single piece seal construction in FIGS. 10 through13, each seal of the disclosed subject matter can be a multi-piece sealassembly, if desired. For example, the seal assembly can include a sealmember and a bushing to provide a backing to the seal member, as knownin the art. As depicted in FIG. 8, the seals 720 and 730 can further besupported by a spacer device, such as proximal and distal bushings 920and 910, respectively. In the embodiment of FIG. 8, the proximal bushing920 is disposed external to the pressure chamber, such as between theproximal seal 720 the proximal movable tubular structure 130 and thedistal bushing 910 is disposed external to the pressure chamber, such asbetween the distal seal 730 and the distal movable tubular structure130. Additional spacer devices can be provided as desired. The cathetercan further include a stopper member 915 coupled to the inner tubularmember 110 distal to the distal seal 730 for additional support. In FIG.8, a bushing 910 is disposed between the distal seal 730 and the stoppermember 915. The stopper and bushings can be constructed of any suitablematerial, including, but not limited to, PEEK, Pebax, HDPE, LDPE, amixture of HDPE and LDPE, a Nylon blend such as L75/L25, or the like.Furthermore, the bushings can comprise a metallic material, combinationlow density polyethelene, silicon, nitric, soft Pebax 30, or otherblends of suitable material, and can be coated with a suitable materialas known in the art, and can include a coating.

As relatively high fluid pressures are needed to retract outer tubularmember 120, the pressure chamber is formed to withstand such pressureswith minimal to no leaks. A variety of suitable seal constructions andmaterials can be used, such as, but not limited to, sliding seals,rings, cups seals, lips seals, and compressed bushings. For example,each seal can be formed as a separate member and attached to thecorresponding tube member, or can be formed as part of the tubularmember. Solely for purposes of illustration, a hydrophilic material,such as, but not limited to, HydroMed™, Hydrothane™, Hydak®, can be usedfor the seals. Seals made of such material can be configured to swellwhen exposed to an aqueous environment, thus sealing more tightly whilemaintaining lubricity. The seals thus can comprise an expandablematerial or composite of materials to increase accordingly to match thedimensions of the outer tubular member. That is, the seal can beconfigured to expand with the outer tubular member to maintain anadequate seal.

As the pressure chamber expands, the exposed surface area of the sealcan also increase, resulting in a proportional increase in retractionforce at a given fluid pressure. Thus, an expanding pressure chamberprovides for greater retraction force at a given pressure. Seals made ofsuch material can be configured to swell when exposed to an aqueousenvironment, thus sealing more tightly while maintaining lubricity.Alternatively, the proximal and distal seals can be coated with ahydrophobic layer such as oil or wax or made of hydrophobic materialsuch as a fluorocarbon or olefins like polypropylene to be used with asuitable pressurized fluid, to prevent swelling of the seals. Solely forexample, silicone seals can be provided with a Hydromer 2314-172coating. In another embodiment, O-rings can be used for the sealconstructions comprised of silicone, buna, or other suitable elastomers.Furthermore, solely for purpose of example, the seal can include softtubing such as a low durometer Pebax. Additionally or alternatively, ahigh viscosity hydraulic fluid can be used to inhibit leaks.

Embodiments of the disclosed subject matter allow the pressure chamberto operate with a variety of different suitable pressures. Solely forpurpose of example, in one embodiment the pressure chamber can handle apositive pressure of up to 750 psi, and a negative pressure ofapproximately 14 psi. An exemplary operating parameter for acardiovascular catheter indications can operate at pressures ranging upto approximately 40 to 50 ATM (or about 588-735 psi).

In accordance with another aspect, the catheter further can includebellows, or a bladder component (not shown) within the chamber toprevent leaks. The bellows or bladder component is attached to theexterior surface of the inner tubular member and is in fluidcommunication with the fluid flow port, wherein fluid introduced throughthe fluid flow port expands the bellows component to further retract theouter tubular member.

In yet another aspect of the disclosed subject matter, spacer elements(not shown) can be provided within the pressure chamber. The spacerelements can prevent the outer tubular member, proximal seal and distalseal from being collapsed during delivery and storage of the catheter.The spacer elements can also reduce the amount of fluid needed toretract the outer tubular member. The spacer elements can be made of anyof a variety of suitable shapes and materials, such as ring membershaving diameters corresponding to the inner and outer diameters of theinner and outer tubular members, respectively.

If desired, the distal seal can form a bumper or stop member for themedical device, such as a stent. In other embodiments, the pressurechamber 450 is spaced from the medical device to be delivered, such asby the use of a distal sheath as previously discussed herein.Alternatively, in accordance with another aspect of the disclosedsubject matter, the catheter can include a stop 710 secured to the innertubular member 110, as depicted in FIGS. 10 and 11. The stop is disposeddistal to the pressure chamber 450 and proximal to the medical device tobe delivered, e.g., the stent. In this manner, the stop 710 seals thehydraulic fluid lumen 310 but allows the guidewire tube 321 and/orguidewire (not shown) to pass through. Stop 710 can be made of orinclude a radiopaque material to provide the physician performing theprocedure with visibility as to placement of the catheter so that themedical device can accurately be positioned at the treatment site. Thestop 710 is thus a radiopaque marker. For example, the marker can be aradiopaque metallic ring, or made of a tungsten loaded polymer forincreased softness and flexibility. Other suitable markers known can beused.

In accordance with another aspect of the disclosed subject matter, otherdevices, such as a spring, can be provided to bias the outer tubularmember 120 in the proximal direction P. Examples of springs and otherdevices that can be implemented with embodiments of the subject mattercan be found in U.S. application Ser. No. 13/467,660, entitled “Catheterhaving Hydraulic Actuator” by Michael Bialas and Michael Green and ownedby Abbott Cardiovascular Systems Inc.; U.S. application Ser. No.13/467,679, entitled “Catheter having Dual Balloon Hydraulic Actuator”by Michael Green and Michael Bialas and owned by Abbott CardiovascularSystems Inc.; and U.S. application Ser. No. 13/467,715, entitled“Catheter having Hydraulic Actuator with Tandem Chambers” by MichaelGreen and Michael Bialas, the contents of which are herein incorporatedby reference in their entirety.

Reference is now made to FIG. 7, solely for purposes of illustration,which depicts an over-the-wire variation of the disclosed subjectmatter. In this embodiment, catheter 100 includes inner tubular member110, outer tubular member 120 (shown in a retracted position), aguidewire lumen 320, and fluid lumen 310 having fluid flow port 420.Catheter 100 further includes medical devices, such as stent 440 asshown in an expanded state, stent seat 510, and a distal guidewire port430.

As shown in FIG. 7A, solely for the purpose of illustration, the innertubular member 110 or elongated catheter shaft of the catheter caninclude first and second tubular members 110 and 610, respectively, incoaxial relationship with each other to define a central guidewire lumen320 within the first tubular member 110 and an annular fluid lumen 310located between the first and second tubular members 610 of the innertubular member or shaft. The fluid lumen 310 can supply a hydraulicmedium under positive pressure and can withdraw the hydraulic medium,i.e., provide negative pressure, from pressure chamber 450 as desired.The catheter is sized and configured for delivery within a correspondingbody lumen for the intended indication, such as a vasculature forvascular intervention. The catheter includes a guidewire lumen fordelivery over a guidewire 620 as shown in FIG. 7A. For example, in oneembodiment such as for neuro indications, the catheter can be 0.012 or0.010 guidewire compatible. The portion of the inner tubular memberextending distal of the chamber can be defined by an extension of thefirst tubular member 110, or an extension of the second tubular member610, or by a separate tubular member as desired. Although a coaxialshaft and over-the-wire (OTW) catheter configuration is depicted in FIG.7, those skilled in the art will recognize that other configurations andknown materials of construction can be used without departing from thescope of the disclosed subject matter, for example, the rapid exchangeand/or dual lumen configurations as previously described.

The pressure chamber 450 can additionally include a locking system toprevent the outer tubular member 120 from prematurely moving in theproximal direction P. The pressure chamber 450 with the locking systemoperates substantially the same as previously described. However, thelocking system restricts the initial movement of the outer tubularmember until suitable pressure is first introduced into the chamber.Examples of suitable locking systems can be found in the currentlypending U.S. application Ser. No. 13/797,636, entitled, “Catheter HavingHydraulic Actuator And Locking System”, assigned to AbbottCardiovascular Systems Inc. and filed on Mar. 12, 2013, the contents ofwhich are incorporated by reference herein in its entirety.

Details regarding the method of making a catheter of the disclosedsubject are understood from the detailed description above. However, themethod generally includes, among other things, providing an innertubular member having a proximal end portion, a distal end portion andan exterior surface, the inner tubular member further having a guidewirelumen defined therein; providing a medical device disposed about thedistal end portion of the inner tubular member, the medical devicehaving a longitudinal length dimension; providing an outer tubularmember movable relative to the inner tubular member, the outer tubularmember having a proximal end, a distal end and an interior surfacedirected toward the exterior surface of the inner tubular member;coupling a movable tubular structure to the outer tubular member; andproviding a proximal stopper having a distal end and disposed proximalto a proximal end of the movable tubular structure, the distal end ofthe proximal stopper being spaced from the proximal end of the movabletubular structure at least the longitudinal length dimension of themedical device, wherein the outer tubular member and the movable tubularstructure are movable in a proximal direction up to engagement of theproximal stopper to deploy the medical device from the inner tubularmember.

Further embodiments of the method include coupling a second movabletubular structure to the outer tubular member at the distal end thereof;and coupling the second movable tubular structure with the movabletubular structure by at least one wire device, wherein the outer tubularmember is movable in the proximal direction with movement of the movabletubular structure to deploy the medical device.

Details regarding the material of the disclosed subject are understoodfrom the detailed description above. Generally, however, a movabletubular structure can be located between the outer tubular member andthe inner tubular member. The movable tubular structure includes a bodymember having an outer surface with a recess defined therein. The outertubular member is received within the recess to form a trough along aportion of an exterior surface of the outer tubular member. A filler isdisposed in the trough. The filler has a suitable hoop strength tocouple the outer tubular member to the body member of the movabletubular structure. As indicated above, the filler can be any of avariety of suitable materials. For example, if a thermally compatiblematerial is provided to bond with the outer tubular member, then themethod can further include providing a shrink wrap over the filler atthe trough. The filler is thermally bonded with the outer tubular memberto secure the outer tubular member with the movable tubular structureand the shrink wrap is removed. A similar method can be used to couplethe distal sheath if provided, to the movable tubular structure. Otherbonding techniques are further contemplated herein, as previouslydiscussed.

In accordance with the embodiments of the subject matter previouslydescribed, the components of the catheter can be made of a variety ofsuitable materials. For example, the proximal and distal seals of theexpandable chamber configuration can be formed of any suitablematerials. Solely for example, the seals can be rubber or silicon. Inembodiments having an expandable pressure chamber, the seals can beformed of a low durometer rubber having a compressed condition and anexpanded condition. The seals can be significantly compressed anddeformed in the initial delivery configuration, transitioning to theexpanded condition when the pressure chamber is pressurized.Alternatively, the seals can be made of hydrophilic polymers that absorbfluid in the pressure chamber and expand along with the outer tubularmember. Alternatively, the proximal and distal seals can be made ofhydrophobic material.

The inner tubular member and outer tubular member each can be a singlepiece construction, or an assembly of components, and can be made of anysuitable material. For example, suitable materials include, but are notlimited to polymer materials such as nylon, urethane, polyurethane,PEEK, PTFE, PVDF, fluoropolymer such as Kynar, PE, HDPE, a trilayermaterial including L25, Plexar, PEBAX, or polyethylene of varioussuitable densities. For example, the outer tubular member can comprise anylon braided tube with a PTFE liner. Additionally a lubricious liner,such as PTFE, on the inside diameter of the outer tubular member, or thesheath, allows the stent to deploy with low force and can prevent theouter tubular member from being bonded to the stent or other cathetercomponents. In another example, the outer tubular member includes afluoropolymer braided tube with lubricous liner. Furthermore, at least aportion of the inner and/or outer tubular members can be constructed ofan alloy or metallic material, such as stainless steel hypodermic tubingor the like.

As a further alternative, the inner tubular member and/or the outermember each can be constructed of multiple outer tubular members. A stopcan further form a joint for two adjacent tubular members. The outertubular member can further be constructed of a composite comprising afabrication of several different materials, such as a co-extrusion ofdifferent polymers, or a fiber-reinforced composite material such asfiber reinforced resin materials or braided materials. Solely forexample, exemplary embodiments can include a braided tube with a PTFEliner, a Polymide middle layer with braiding and a Pebax 72D outerlayer. Additionally, to improve flexibility, helical or spiral memberconfigurations can be used in the construction of the inner and outertubular members.

Exemplary constructions for the outer tubular member include a singlelayer of polyimide or PEEK; a trilayer material of L25, Plexar, HDPE; ora braided tube with a PTFE liner, a Polyimide middle layer braidingmiddle layer, and a Pebax 72D outer layer. The inner and/or outertubular members can also be reinforced by the addition of astrengthening member, such as, for example, a wire coil. In oneembodiment, the inner tubular member is reinforced by the addition of astrengthening member along a length corresponding to the pressurechamber.

It is further contemplated that the inner and outer tubular members canbe constructed of other biocompatible material. As such, the inner andouter tubular members of the catheter can be constructed from theabove-identified polymers, combinations or blends of these polymers,whether alone or in combination with other materials, or otherbioabsorbable materials.

The inner and outer tubular members can be manufactured using a varietyof known techniques such as but not limited to: extrusion, injectionmolding, air-blowing, stretching, deep drawing, polymerization,cross-linking, dipping from solution, powder depositioning, sintering,electro-spinning, melt spinning, deformation under temperature, stretchblowing, chemical grafting any combination of the above withreinforcement element like metal braids, coils, glass fibers, carbonfibers and other kind of organic or inorganic fibers, liquid crystals,as well as classical machining technologies like milling, drilling,grinding, etc. In the event that metallic elements such as hypotubes areto be incorporated, various metallic manufacturing techniques can beused, such as but not limited to, machining, tube drawing processes,drilling, milling, EDM, other deformation methods, plating, sputtering,electrografting, sintering, and depositioning e-polishing, among others.In one embodiment of the disclosed subject matter, the inner tubularmember includes a stainless steel hypotube at least at its proximal end.

Additionally, the inner and outer tubular members can be constructedfrom PE, polypropylene, Kynar, or urethane by an extrusion process usingan extruder such as that available from any of a number of knownsuppliers. The materials can be post-processed in a number of waysincluding, for example and not by way of limitation, extrusion, molding,such as by injection or dipping, textile processing such as weaving orbraiding, and forming. Forming processes that can be suitable arerolling and welding sheets of material or vacuum forming into tubularshapes, to name only a few examples.

The inner and outer tubular members can be further coated with any of avariety of materials and techniques to enhance performance if desired,including a number of suitable coatings and coating techniques subjectto patent matters owned by Abbott Laboratories such as U.S. Pat. No.6,541,116, 6,287,285, and 6,541,116, the entireties of which are herebyincorporated by reference. For example, possible coating materialsinclude lubricious materials such as Teflon®, and hydrophobic materialssuch as silicone lubricant dispersion PN 4097, or hydrophilic materialssuch as hydrogel, or lubricious coatings.

The inner and outer tubular members can have any suitablecross-sectional shape, including elliptical, polygon, or prismatic,although a circular cross-section generally is preferred. The inner andouter tubular members can also have any suitable size and diameterdepending upon the desired application. The catheter is suitably sizedand configured for delivery within a corresponding body lumen for theintended indication, such as a vasculature for vascular intervention.

According to one embodiment, the outer tubular member can include anouter layer and an inner layer. The outer tubular member can be providedwith an inner layer attached to or formed with an outer layer. The innerlayer or liner can include a lubricious material to facilitate thesliding of the outer tubular member in a proximal direction when theouter tubular member is retracted. For example, different types ofpolymers such as PTFE or high-density polyethylene (HDPE) can be usedfor the inner layer. Additionally, other lubricious polymers can beused. The outer layer, as embodied herein, provides sufficient strengthto capture a medical device therein, as well as allow movement betweenthe first position and the second position. The multiple layers can beformed separately and adhered or bonded together or co-extruded as asingle member.

In further accordance with the disclosed subject matter the outertubular member can include a reinforcing layer disposed between theouter layer and the inner layer, such as a braided material. Forexample, the reinforcing layer can be provided in the form of a braidedstainless steel tube or sheet or the like. The braid can includeflattened filaments, as opposed to having filaments with a roundcross-section. Alternatively, the reinforcement can be in the form of atube including woven fabric or appropriately oriented filaments, such ascarbon fibers encased in a polymeric matrix. Likewise, such reinforcingfibers could additionally or alternatively be incorporated into innerlayer and/or outer layer during the manufacturing process.

When the outer tubular member is provided with an inner layer, outerlayer and a reinforcing layer, the outer tubular member can be formed inthe following manner. First, inner layer is formed through a tubularextrusion process, and disposed about a forming mandrel (not shown). Theforming mandrel, as embodied herein, has a shape that corresponds to thedesired shape of the inside of the outer tubular member. Next, thereinforcing layer, which can be provided in the form of a stainlesssteel braid material, is positioned over a predetermined length of innerlayer. Next, the outer layer is extruded and positioned over thereinforcing layer. The outer layer can be provided in the form of twoseparate tubular members that are overlapped slightly at their ends overreinforcing layer. Each portion of outer layer can be a differentmaterial selected to provide a different durometer as described above.The two portions of outer layer can overlap by an amount such asapproximately 0.1 inches. Next, a sleeve of heat shrinkable material ispositioned over the entire outer tubular member assembly. Finally, heatis applied to the assembly. When heat is applied, the heat shrinkabletubing shrinks, and causes inner layer to fuse with outer layer,trapping reinforcing layer therebetween. The heating process also causesinner layer to conform to the shape of the forming mandrel. After theassembly cools, the heat shrinkable tubing is cut away, leaving behindthe outer tubular member.

While the disclosed subject matter is described herein in terms ofcertain preferred embodiments, those skilled in the art will recognizethat various modifications and improvements can be made to the disclosedsubject matter without departing from the scope thereof. Additionalfeatures known in the art likewise can be incorporated, such asdisclosed in U.S. Pat. No. 7,799,065 to Pappas, which is incorporated inits entirety by reference herein. Moreover, although individual featuresof one embodiment of the disclosed subject matter can be discussedherein or shown in the drawings of the one embodiment and not in otherembodiments, it should be apparent that individual features of oneembodiment can be combined with one or more features of anotherembodiment or features from a plurality of embodiments.

In addition to the various embodiments depicted and claimed, thedisclosed subject matter is also directed to other embodiments havingany other possible combination of the features disclosed and claimedherein. As such, the particular features presented herein can becombined with each other in other manners within the scope of thedisclosed subject matter such that the disclosed subject matter includesany suitable combination of the features disclosed herein. Furthermore,although reference is made to a stent throughout this disclosure, othersuitable devices and implants likewise can be delivered using thecatheter and system disclosed herein. Thus, the foregoing description ofspecific embodiments of the disclosed subject matter has been presentedfor purposes of illustration and description. It is not intended to beexhaustive or to limit the disclosed subject matter to those embodimentsdisclosed.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the method and system of thedisclosed subject matter without departing from the spirit or scope ofthe disclosed subject matter. Thus, it is intended that the disclosedsubject matter include modifications and variations that are within thescope of the appended claims and their equivalents.

For example, and further to the detailed description above, thedisclosed subject matter herein can include one or more of thefollowing:

Embodiment 1

A catheter comprising: an inner tubular member having a proximal endportion, a distal end portion and an exterior surface, the inner tubularmember further having a guidewire lumen defined therein; an outertubular member movable relative to the inner tubular member, the outertubular member having a proximal end, a distal end and an interiorsurface directed toward the exterior surface of the inner tubularmember; a medical device disposed about the distal end portion of theinner tubular member, the medical device having a longitudinal lengthdimension; a movable tubular structure coupled to the outer tubularmember; and a proximal stopper having a distal end and disposed proximalto a proximal end of the movable tubular structure, the distal end ofthe proximal stopper being spaced from the proximal end of the movabletubular structure at least the longitudinal length dimension of themedical device, wherein the outer tubular member and the movable tubularstructure are movable in a proximal direction up to engagement of theproximal stopper to deploy the medical device from the inner tubularmember.

Embodiment 2

The catheter of Embodiment 1, wherein the longitudinal length dimensionof the medical device comprises a range from approximately 10 mm toapproximately 250 mm.

Embodiment 3

The catheter of any of the foregoing Embodiments, wherein the medicaldevice comprises an outer cross dimensional profile ranging fromapproximately 2 French to approximately 6 French.

Embodiment 4

The catheter of any of the foregoing Embodiments, wherein the medicaldevice comprises a self-expanding stent.

Embodiment 5

The catheter of any of the foregoing Embodiments, wherein the movabletubular structure is disposed between the outer tubular member and theinner tubular member, the movable tubular structure comprising a bodymember having an outer surface with a recess defined therein, the outertubular member received within the recess to form a trough along aportion of an exterior surface of the outer tubular member, the troughhaving a filler disposed therein to couple the outer tubular member tothe body member of the movable tubular structure.

Embodiment 6

The catheter of any of the foregoing Embodiments, wherein the movabletubular structure is disposed external to a body lumen during deploymentof the medical device.

Embodiment 7

The catheter of any of the foregoing Embodiments, wherein the movabletubular structure includes a proximal movable tubular structure and adistal movable tubular structure, wherein a pressure chamber is definedbetween the proximal and distal movable tubular structures.

Embodiment 8

The catheter of any of the foregoing Embodiments, further comprising asecond movable tubular structure coupled to the distal end of the outertubular member; and a distal sheath coupled to the outer tubular memberby the second movable tubular structure, the distal sheath disposedabout the medical device and being movable relative the inner tubularmember by movement of the outer tubular member in the proximal directionto deploy the medical device from the inner tubular member.

Embodiment 9

The catheter of any of the foregoing Embodiments, wherein the distalsheath comprises a suitable hoop strength and a suitable flexibility tocover and secure the medical device on the inner tubular member.

Embodiment 10

The catheter of any of the foregoing Embodiments, wherein the distal endof the proximal stopper is spaced from the proximal end of the movabletubular structure approximately the longitudinal length dimension of themedical device.

Embodiment 11

The catheter of any of the foregoing Embodiments, wherein the distal endof the proximal stopper is spaced approximately 12 mm to approximately312 mm from the proximal end of the movable tubular structure.

Embodiment 12

The catheter of any of the foregoing Embodiments, further comprising aproximal adapter, wherein the proximal stopper is disposed distal to andproximate to the proximal adapter.

Embodiment 13

The catheter of any of the foregoing Embodiments, wherein the innertubular member has a fluid lumen defined therein, the fluid lumen havinga fluid flow port defined by the exterior surface along the distal endportion of the inner tubular member, the catheter further comprising: aproximal seal extending from the interior surface of the outer tubularmember toward the exterior surface of the inner tubular member, theproximal seal located proximal to the fluid flow port; a distal sealextending from the exterior surface of the inner tubular member towardthe interior surface of the outer tubular member, the distal seallocated distal to the fluid flow port; and a pressure chamber defined bythe proximal seal, the distal seal, the exterior surface of the innertubular member, and interior surface of the outer tubular member, withthe pressure chamber in fluid communication with the fluid flow port,wherein fluid introduced through the fluid flow port and into thepressure chamber applies a force on the proximal seal to urge the outertubular member and the movable tubular structure in the proximaldirection.

Embodiment 14

The catheter of any of the foregoing Embodiments, a second movabletubular structure coupled to the outer tubular member at a distal end ofthe catheter; and at least one wire device to couple the second movabletubular structure with the movable tubular structure, wherein the outertubular member is movable in the proximal direction with movement of themovable tubular structure to deploy the medical device.

Embodiment 15

The catheter of any of the foregoing Embodiments, wherein the at leastone wire device is disposed within the catheter along a lumen definedtherein.

Embodiment 16

The catheter of Embodiments 1 through 14, wherein the at least one wiredevice is disposed between the outer tubular member and the innertubular member.

Embodiment 17

The catheter of any of the foregoing Embodiments, wherein the at leastone wire device comprises a first and second wire.

Embodiment 18

The catheter of Embodiments 1 through 16, wherein the at least one wiredevice comprises up to 10 wires.

Embodiment 19

The catheter of any of the foregoing Embodiments, further comprising adistal sheath coupled to the outer tubular member by the second movabletubular structure, the distal sheath disposed about the medical deviceand being movable relative the inner tubular member by movement of theat least one wire device in the proximal direction to deploy the medicaldevice from the inner tubular member.

Embodiment 20

The catheter of any of the foregoing Embodiments, wherein the distalsheath has an outer cross dimension greater than an outer crossdimension of the outer tubular member.

Embodiment 21

The catheter of any of the foregoing Embodiments, wherein the distalsheath has a flexibility and a stiffness different than a flexibilityand stiffness of the outer tubular member.

Embodiment 22

The catheter of any of the foregoing Embodiments, wherein the outercross dimension of the distal sheath is between approximately 2 Frenchto approximately 6 French.

Embodiment 23

A catheter comprising: an inner tubular member having a proximal endportion, a distal end portion and an exterior surface, the inner tubularmember further having a guidewire lumen and a fluid lumen definedtherein, the fluid lumen having a fluid flow port defined by theexterior surface along the distal end portion of the inner tubularmember; an outer tubular member movable relative to the inner tubularmember, the outer tubular member having a proximal end, a distal end andan interior surface directed toward the exterior surface of the innertubular member; a first movable tubular structure coupled to the outertubular member and disposed at the proximal end of the outer tubularmember; a second movable tubular structure coupled to the outer tubularmember and disposed at the distal end of the outer tubular member; adistal sheath coupled to the outer tubular member by the second movabletubular member, the distal sheath movable relative the inner tubularmember by movement of the outer tubular member; a proximal sealextending from the interior surface of the outer tubular member towardthe exterior surface of the inner tubular member, the proximal seallocated proximal to the fluid flow port; a distal seal extending fromthe exterior surface of the inner tubular member toward the interiorsurface of the outer tubular member, the distal seal located distal tothe fluid flow port; and a pressure chamber defined by the proximalseal, the distal seal, the exterior surface of the inner tubular member,and interior surface of the outer tubular member, the pressure chamberdisposed proximal to the first movable tubular structure and in fluidcommunication with the fluid flow port, wherein fluid introduced throughthe fluid flow port and into the pressure chamber applies a force on theproximal seal to urge the outer tubular member, the first movabletubular structure, and the second movable tubular structure in theproximal direction.

Embodiment 24

The catheter of Embodiment 23, wherein the pressure chamber is disposedproximate the proximal end of the inner tubular member prior todeployment.

Embodiment 25

The catheter of Embodiments 23 and 24, further comprising a medicaldevice disposed about the distal end portion of the inner tubularmember, wherein the distal sheath is disposed about the medical deviceand movement of the distal sheath in the proximal direction deploys themedical device from the inner tubular member.

Embodiment 26

The catheter of Embodiments 23 through 25, wherein the distal sheath ismovable in the proximal direction a length approximately correspondingto a longitudinal length of the medical device.

Embodiment 27

A method of making a catheter comprising: providing an inner tubularmember having a proximal end portion, a distal end portion and anexterior surface, the inner tubular member further having a guidewirelumen defined therein; providing a medical device disposed about thedistal end portion of the inner tubular member, the medical devicehaving a longitudinal length dimension; providing an outer tubularmember movable relative to the inner tubular member, the outer tubularmember having a proximal end, a distal end and an interior surfacedirected toward the exterior surface of the inner tubular member;coupling a movable tubular structure to the outer tubular member; andproviding a proximal stopper having a distal end and disposed proximalto a proximal end of the movable tubular structure, the distal end ofthe proximal stopper being spaced from the proximal end of the movabletubular structure at least the longitudinal length dimension of themedical device, wherein the outer tubular member and the movable tubularstructure are movable in a proximal direction up to engagement of theproximal stopper to deploy the medical device from the inner tubularmember.

Embodiment 28

The catheter of Embodiment 27, further comprising coupling a secondmovable tubular structure to the outer tubular member at the distal endthereof; and coupling the second movable tubular structure with themovable tubular structure by at least one wire device, wherein the outertubular member is movable in the proximal direction with movement of themovable tubular structure to deploy the medical device.

What is claimed is:
 1. A catheter comprising: an inner tubular memberhaving a proximal end portion, a distal end portion and an exteriorsurface, the inner tubular member further having a guidewire lumendefined therein; an outer tubular member movable relative to the innertubular member, the outer tubular member having a proximal end, a distalend and an interior surface directed toward the exterior surface of theinner tubular member; a medical device disposed about the distal endportion of the inner tubular member, the medical device having alongitudinal length dimension; a proximal tubular structure moveablerelative to the inner tubular member and a distal tubular structuremoveable relative to the inner tubular member, wherein each of theproximal and distal tubular structures is coupled to the outer tubularmember; a distal sheath coupled to the outer tubular member by thedistal tubular structure, wherein the distal sheath extends distallybeyond the distal end of the outer tubular member and has an outer crossdimension less than an outer cross dimension of the outer tubularmember; a pressure chamber defined between the proximal and distaltubular structures; and a proximal stopper having a distal end anddisposed proximal to a proximal end of at least one of the proximal anddistal tubular structures, the distal end of the proximal stopper beingspaced from the proximal end of the at least one of the proximal anddistal tubular structures at least the longitudinal length dimension ofthe medical device, wherein the outer tubular member and the proximaltubular structure are movable in a proximal direction up to engagementof the proximal stopper to deploy the medical device from the innertubular member.
 2. The catheter according to claim 1, wherein thelongitudinal length dimension of the medical device comprises a rangefrom approximately 10 mm to approximately 250 mm.
 3. The catheteraccording to claim 1, wherein the medical device comprises an outercross dimensional profile ranging from approximately 2 French toapproximately 6 French.
 4. The catheter according to claim 1, whereinthe medical device comprises a self-expanding stent.
 5. The catheteraccording to claim 1, wherein at least one of the proximal or distaltubular structures is disposed between the outer tubular member and theinner tubular member, the at least one of the proximal or distal tubularstructures disposed between the outer tubular member and the innertubular member comprising a body member having an outer surface with arecess defined therein, the outer tubular member received within therecess to form a trough along a portion of an exterior surface of theouter tubular member, the trough having a filler disposed therein tocouple the outer tubular member to the body member of the at least oneof the proximal or distal tubular structures.
 6. The catheter accordingto claim 1, wherein the at least one of the proximal or distal tubularstructures is disposed external to a body lumen during deployment of themedical device.
 7. The catheter accordingly to claim 1, wherein thedistal sheath is disposed about the medical device and movable relativethe inner tubular member by movement of the outer tubular member in theproximal direction to deploy the medical device from the inner tubularmember.
 8. The catheter according to claim 1, wherein the distal sheathcomprises a suitable hoop strength and a suitable flexibility to coverand secure the medical device on the inner tubular member.
 9. Thecatheter according to claim 1, wherein the distal end of the proximalstopper is spaced from the proximal end of the proximal tubularstructure approximately the longitudinal length dimension of the medicaldevice.
 10. The catheter according to claim 1, wherein the distal end ofthe proximal stopper is spaced approximately 12 mm to approximately 312mm from the proximal end of the proximal tubular structure.
 11. Thecatheter according to claim 1, further comprising a proximal adapter,wherein the proximal stopper is disposed distal to and proximate to theproximal adapter.
 12. The catheter according to claim 1, wherein theinner tubular member has a fluid lumen defined therein, the fluid lumenhaving a fluid flow port defined by the exterior surface along thedistal end portion of the inner tubular member, the catheter furthercomprising: a proximal seal extending from the interior surface of theouter tubular member toward the exterior surface of the inner tubularmember, the proximal seal located proximal to the fluid flow port; adistal seal extending from the exterior surface of the inner tubularmember toward the interior surface of the outer tubular member, thedistal seal located distal to the fluid flow port; and the pressurechamber being defined by the proximal seal, the distal seal, theexterior surface of the inner tubular member, and interior surface ofthe outer tubular member, with the pressure chamber in fluidcommunication with the fluid flow port, wherein fluid introduced throughthe fluid flow port and into the pressure chamber applies a force on theproximal seal to urge the outer tubular member and the proximal anddistal tubular structures in the proximal direction.
 13. The catheteraccording to claim 1, further comprising: a second movable tubularstructure coupled to the outer tubular member at a distal end of thecatheter; and at least one wire device to couple the second movabletubular structure with the distal tubular structure.
 14. The catheteraccording to claim 13, wherein the at least one wire device is disposedwithin the catheter along a lumen defined therein.
 15. The catheteraccording to claim 13, wherein the at least one wire device is disposedbetween the outer tubular member and the inner tubular member.
 16. Thecatheter according to claim 13, wherein the at least one wire devicecomprises a first and second wire.
 17. The catheter according to claim13, wherein the at least one wire device comprises up to 10 wires. 18.The catheter according to claim 13, wherein the distal sheath isdisposed about the medical device and movable relative the inner tubularmember by movement of the at least one wire device in the proximaldirection to deploy the medical device from the inner tubular member.19. The catheter according to claim 18, wherein the distal sheath has aflexibility and a stiffness different than a flexibility and stiffnessof the outer tubular member.
 20. The catheter according to claim 18,wherein the outer cross dimension of the distal sheath is betweenapproximately 2 French to approximately 6 French.
 21. A cathetercomprising: an inner tubular member having a proximal end portion, adistal end portion and an exterior surface, the inner tubular memberfurther having a guidewire lumen and a fluid lumen defined therein, thefluid lumen having a fluid flow port defined by the exterior surfacealong the distal end portion of the inner tubular member; an outertubular member movable relative to the inner tubular member, the outertubular member having a proximal end, a distal end and an interiorsurface directed toward the exterior surface of the inner tubularmember; a first tubular structure moveable relative to the inner tubularmember, coupled to the outer tubular member, and disposed at theproximal end of the outer tubular member; a second tubular structuremoveable relative to the inner tubular member, coupled to the outertubular member, and disposed at the distal end of the outer tubularmember; a distal sheath coupled to the outer tubular member by thesecond tubular member, the distal sheath movable relative the innertubular member by movement of the outer tubular member, wherein thedistal sheath has an outer cross dimension less than an outer crossdimension of the outer tubular member; a proximal seal extending fromthe interior surface of the outer tubular member toward the exteriorsurface of the inner tubular member, the proximal seal located proximalto the fluid flow port; a distal seal extending from the exteriorsurface of the inner tubular member toward the interior surface of theouter tubular member, the distal seal located distal to the fluid flowport; and a pressure chamber defined by the proximal seal, the distalseal, the exterior surface of the inner tubular member, and the interiorsurface of the outer tubular member, the pressure chamber disposedproximal to the second tubular structure and in fluid communication withthe fluid flow port, wherein fluid introduced through the fluid flowport and into the pressure chamber applies a force on the proximal sealto urge the outer tubular member, the first tubular structure, and thesecond tubular structure in the proximal direction.
 22. The catheteraccording to claim 21, wherein the pressure chamber is disposedproximate the proximal end of the inner tubular member prior todeployment.
 23. The catheter according to claim 21, further comprising amedical device disposed about the distal end portion of the innertubular member, wherein the distal sheath is disposed about the medicaldevice and movement of the distal sheath in the proximal directiondeploys the medical device from the inner tubular member.
 24. Thecatheter according to claim 23, wherein the distal sheath is movable inthe proximal direction a length approximately corresponding to alongitudinal length of the medical device.
 25. A catheter comprising: aninner tubular member having a proximal end portion, a distal end portionand an exterior surface, the inner tubular member further having aguidewire lumen defined therein; an outer tubular member movablerelative to the inner tubular member, the outer tubular member having aproximal end, a distal end and an interior surface directed toward theexterior surface of the inner tubular member; a medical device disposedabout the distal end portion of the inner tubular member, the medicaldevice having a longitudinal length dimension; a proximal tubularstructure moveable relative to the inner tubular member and a distaltubular structure moveable relative to the inner tubular member, whereineach of the proximal and distal tubular structures is coupled to theouter tubular member; a distal sheath coupled to the outer tubularmember by the distal tubular structure, wherein the distal sheath has anouter cross dimension less than an outer cross dimension of the outertubular member, wherein the distal sheath is disposed about the medicaldevice and movable relative the inner tubular member by movement of theouter tubular member in the proximal direction to deploy the medicaldevice from the inner tubular member; a pressure chamber defined betweenthe proximal and distal tubular structures; and a proximal stopperhaving a distal end and disposed proximal to a proximal end of at leastone of the proximal and distal tubular structures, the distal end of theproximal stopper being spaced from the proximal end of the at least oneof the proximal and distal tubular structures at least the longitudinallength dimension of the medical device, wherein the outer tubular memberand the proximal tubular structure are movable in a proximal directionup to engagement of the proximal stopper to deploy the medical devicefrom the inner tubular member.
 26. A catheter comprising: an innertubular member having a proximal end portion, a distal end portion andan exterior surface, the inner tubular member further having a guidewirelumen defined therein; an outer tubular member movable relative to theinner tubular member, the outer tubular member having a proximal end, adistal end and an interior surface directed toward the exterior surfaceof the inner tubular member; a medical device disposed about the distalend portion of the inner tubular member, the medical device having alongitudinal length dimension; a proximal tubular structure moveablerelative to the inner tubular member and a distal tubular structuremoveable relative to the inner tubular member, wherein each of theproximal and distal tubular structures is coupled to the outer tubularmember; a distal sheath coupled to the outer tubular member by thedistal tubular structure, wherein the distal sheath has an outer crossdimension less than an outer cross dimension of the outer tubularmember, wherein the distal sheath comprises a suitable hoop strength anda suitable flexibility to cover and secure the medical device on theinner tubular member; a pressure chamber defined between the proximaland distal tubular structures; and a proximal stopper having a distalend and disposed proximal to a proximal end of at least one of theproximal and distal tubular structures, the distal end of the proximalstopper being spaced from the proximal end of the at least one of theproximal and distal tubular structures at least the longitudinal lengthdimension of the medical device, wherein the outer tubular member andthe proximal tubular structure are movable in a proximal direction up toengagement of the proximal stopper to deploy the medical device from theinner tubular member.